Authors' objectives: Lateral compression type-1 pelvic fractures are a common fragility fracture in older adults. Patients who do not mobilise due to ongoing pain are at greater risk of immobility-related complications. Standard treatment in the United Kingdom is provision of pain relief and early mobilisation, unlike fragility hip fractures, which are usually treated surgically based on evidence that early surgery is associated with better outcomes. Currently there is no evidence on whether patients with lateral compression type-1 fragility fractures would have a better recovery with surgery than non-surgical management. To assess the clinical and cost effectiveness of surgical fixation with internal fixation device compared to non-surgical management of lateral compression type-1 fragility fractures in older adults. Lateral compression type-1 (LC-1) pelvic fractures are a common fragility fracture in older adults. Older patients who do not get back walking following an LC-1 fracture due to ongoing pain are at greater risk of immobility-related complications. In the UK, standard treatment for LC-1 fragility fracture is to ‘mobilise as pain allows’, involving prescribing pain relief, getting patients up within a few days of injury with physiotherapy input and encouraging them to mobilise with an assistive device until the fracture heals. This is unlike fragility hip fractures (fractures involving the upper end of the femur) where there is evidence that early surgery (within 1–2 days) is associated with reduced risk of death and pressure sores and these fractures are usually treated surgically. Despite LC-1 fractures being similarly disabling for some patients in terms of pain and immobility and occurring in the same patient group as hip fractures, to date, it has not been shown whether elderly patients with LC-1 fractures would have a better recovery with surgery than non-surgical management. To assess the clinical and cost effectiveness of surgical fixation with internal fixation device (INFIX) compared to non-surgical management of LC-1 fragility fractures in older adults (L1FE trial): undertake a 12-month internal pilot to obtain robust estimates of recruitment and confirm trial feasibility undertake a parallel group multicentre randomised controlled trial (RCT) to assess the effectiveness of surgical fixation with INFIX versus non-surgical management of LC-1 fragility fractures in older adults undertake an economic evaluation to compare the cost effectiveness of surgical fixation compared to non-surgical management, to determine the most efficient provision of future care and to describe the resource impact on the NHS for the two treatment options undertake a long-term review of patient well-being [EuroQol-5 Dimensions, five-level version (EQ-5D-5L) and mortality] 12 months after entering the trial.

Authors' results and conclusions: The trial closed early, at the end of the internal pilot, due to low recruitment. The internal pilot was undertaken in two separate phases because of a pause in recruitment due to the coronavirus disease 2019 pandemic. The planned statistical and health economic analyses were not conducted. Outcome data were summarised descriptively. Eleven sites opened for recruitment for a combined total of 92 months. Three-hundred and sixteen patients were assessed for eligibility, of whom 43 were eligible (13.6%). The main reason for ineligibility was that the patient was able to mobilise independently to 3 m and back (n = 161). Of the 43 eligible participants, 36 (83.7%) were approached for consent, of whom 11 (30.6%) provided consent. The most common reason for eligible patients not consenting to take part was that they were unwilling to be randomised to a treatment (n = 10). There were 11 participants, 5 randomised to surgical management with internal fixation device and 6 to non-surgical management. The average age of participants was 83.0 years (interquartile range 76.0, 89.0) and the EuroQol-5 Dimensions, five-level version utility score at 6 months post randomisation (n = 8) was 0.32 (standard deviation 0.37). A limitation of the trial was that study objectives were not addressed due to poor recruitment. It was not feasible to recruit to this trial in the current context. Further research to understand the treatment and recovery pathways of this group of patients, along with their outcomes, would be needed prior to undertaking a future trial. The trial closed early, at the end of the internal pilot due to low recruitment. The internal pilot took place in two separate phases (August 2019 to March 2020 and March 2021 to September 2021) because of a 1-year recruitment pause due to the coronavirus disease 2019 (COVID-19) pandemic. Site set-up Eleven sites in England and Wales were opened during the first phase of the internal pilot. Ten of these re-opened following the study recruitment pause. A further 10 sites, including 3 in Scotland, were interested in participating and were in various stages of set-up prior to study closure. The 11 sites were open for a combined total of 92 months. It is not feasible to recruit to this trial in the current context. Further research to understand the treatment and recovery pathways of this group of patients, along with their outcomes, would be needed prior to undertaking a future trial.

Authors' methods: Pragmatic, randomised controlled superiority trial, with 12-month internal pilot; target sample size was 600 participants. Participants were randomised between surgical and non-surgical management (1 : 1 allocation ratio). An economic evaluation was planned. UK Major Trauma Centres. Patients aged 60 years or older with a lateral compression type-1 pelvic fracture, arising from a low-energy fall and unable to mobilise independently to a distance of 3 m and back due to pelvic pain 72 hours after injury. Internal fixation device surgical fixation and non-surgical management. Participants, surgeons and outcome assessors were not blinded to treatment allocation. Primary outcome – average patient health-related quality of life, over 6 months, assessed by the EuroQol-5 Dimensions, five-level version utility score. Secondary outcomes (over the 6 months following injury) – self-rated health, physical function, mental health, pain, delirium, displacement of pelvis, mortality, complications and adverse events, and resource use data for the economic evaluation. Pragmatic, randomised controlled superiority trial, with 12-month internal pilot to assess recruitment assumptions, and an economic evaluation. Participants were randomised between INFIX surgical fixation and non-surgical management of LC-1 pelvic fracture with a 1 : 1 allocation ratio. The target sample size was 600 participants. For the internal pilot the target was to set up a minimum of 19 recruitment sites and randomise 148 participants in order to meet the target sample size in the main trial. To progress to the main trial, an average recruitment rate of one participant per centre per month was required. Participants were recruited from Major Trauma Centres (MTCs) in the UK. Adults aged 60 years or older with an LC-1 pelvic fracture, arising from a low-energy fall from standing height or less, and unable to mobilise independently to a distance of around 3 m and back due to pelvic pain 72 hours after injury were eligible for inclusion. Internal fixation device surgical fixation and non-surgical management (both groups received pain relief and were seen by a physiotherapy team who worked to mobilise the patients as pain allowed). Internal fixation device surgery uses an INFIX to stabilise the pelvis. INFIX devices have screws that are secured into the pelvic bone, and these are connected by a metal bar across the front of the patient. The INFIX device sits entirely under the patient’s skin. Primary outcome – average patient health-related quality of life, over 6 months, assessed by the patient-reported outcome measure, EQ-5D-5L utility score. Collected at baseline, 2 weeks, 6 weeks, 12 weeks and 6 months post-randomisation time points. Secondary outcomes – health-related quality of life using the EQ-5D-5L visual analogue scale (VAS); physical function using the eight-item Patient-Reported Outcome Measures Information System (PROMIS) lower extremity function (LEF) (mobility) – Short Form and Timed Up and Go (TUG) test; mental health using the PROMIS Scale v1.2 – Global Health Mental 2a subscale; pelvic pain using a VAS; delirium using the Abbreviated Mental Test Score (AMTS) and 4AT Rapid Assessment Test for Delirium; displacement of the pelvis based on a radiological assessment at the 12-week visit; mortality; complications and adverse events including lateral cutaneous nerve injury which was an adverse event of special interest (AESI); resource use; long-term review of patient well-being using the EQ-5D-5L and mortality at 12 months (optional follow-up for those recruited early in the trial). Information on resource use such as length of hospital stay, medication use, surgery details and details of rehabilitation therapy received was collected throughout the follow-up period to assess the impact on the NHS as part of the economic evaluation.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/16/167/57

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/LAPW3412

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/LAPW3412

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk